SAAMnow will be presenting an important webinar about addressing the challenges facing the development of Biosimilar drug products on June 7th, 2023. This webinar will include two presenters. First, you will hear from Susan Kirshner, Ph.D., Director of the FDA’s Division of Biotechnology Review and Research III who will provide valuable information about meeting the FDA’s requirements for assessing the potential immunogenicity of your prospective product. Next, Jeffery Baker, Ph.D., Sr. Fellow, NIIMBL and Sr. Strategic Advisor at MIT’s Center for Biomedical Innovation and former Deputy Director of FDA’s Office of Biotechnology Products, will discuss the myriad challenges that companies face beyond the demonstration of biosimilarity.
The webinar will commence at 12:00 noon (EDT) and be approximately 1.5 hours in duration including 20 – 30 minute question & answer session with the speakers.
Registration is free for attendees. Current members of SAAMnow will have online access to content from these webinars. Non-members will have live access to the webinars for which they registered but will not have access to the content after those events have ended.
Why Should You Attend:
This webinar will provide valuable information for those working on the development of, or considering developing, biosimilar drug products.
Webinar: Meeting the Challenges of Biosimilar Product Approval
When: Wednesday, June 7th | 12:00 pm EDT (Eastern US) | Duration: 90 minutes
Presenter 1: Susan Kirshner, PhD, Director, Division of Biotechnology Review and Research III, Office of Biotechnology Products, CDER, FDA
Talk Title: Immunogenicity Assessment of Biosimilar Drug Products
Abstract:
Potential differences in immunogenicity between the reference product and the planned biosimilar product is one of the most significant challenges to the development of an approvable 351(K) application. This presentation will discuss the FDA’s perspective on how to comparatively assess immunogenicity to ensure that this will not be a show-stopper for your application.
Presenter 2: Jeffery Baker, PhD, Sr. Fellow, NIIMBL and Sr. Strategic Advisor, Center for Biomedical Innovation, MIT and Former Deputy Director, Office of Biotechnology Products, CDER, FDA
Talk Title: The Lessons We Already Knew: Unfortunate Stumbles in Biosimilar Submissions
Abstract:
It is widely understood that there are the same expectations for quality (CMC) for a 351(k) biosimilars submission and a 351(a) originating submission and that both submissions are BLAs under the Public Health Service Act. Nevertheless, there are many instances of submissions with fully adequate or even quite strong analytical characterization packages assessing product similarity that nonetheless have had approval compromised by inadequate process characterization or control, document management or assay transfer issues, or troubled manufacturing inspections. This talk will present examples of some of these shortfalls and reflect upon workforce development issues as a contributing factor.